Existing urinary catheter technology results in numerous health and safety issues for patients, medical personnel, and the community at large. The technology of indwelling urinary catheters has barely changed over the last 50 years. Improvements in existing urinary catheter systems are highly desirable. A urinary catheter drainage system is made up of the catheter itself, which is inserted into the bladder, and the urine collection device, which attaches to the catheter with tubing and collects the urine into a receptacle. One example of a urine collection device is a bedside drainage bag, which usually includes a tube connected to the catheter leading to a large bag that hangs on the bedside to collect the urine. Another example is a leg bag, which is worn when a patient is up and around and includes a shorter tube attached to a smaller bag that is attached to the leg and collects urine.
The complications associated with catheterization of the bladder include catheter associated urinary tract infections (CAUTI's), blockage (due to struvite or biofilm formation), bladder atony (causing a short term or permanent inability to void), bladder spasms, and thickening of the bladder wall from long term use.
In addition to direct patient complications, there are numerous safety issues related to current urinary catheter systems, both in the inpatient setting and in the home health setting. Present systems put clinicians at risk of occupational injury related to bio-hazardous waste exposure. Clinicians are frequently sprayed with urine when attempting to irrigate clogged catheters, such as when pressure from the irrigation syringe causes swelling of the catheter and spray back to occur. Because the current available catheter technology demands that the catheter be disconnected from the urine collection device in order to irrigate the system, leaking or spilling of urine often occurs during these procedures. When these spills and splashes occur, clinicians, other patients, and the community at large are put at risk for cross contamination and the spread of infection, including antibiotic resistant pathogens.
In summary, most of the problems listed above arise, at least in part, from two primary problems with existing catheter systems: (1) Current catheter systems do not allow for the maintenance of a closed, aseptic system; and (2) Current catheter systems do not allow the bladder to fill and empty in a normal fashion.
About 30% of CAUTI's are shown to be caused by intraluminal bacterial biofilm formation. The primary way that bacteria enter the inner lumen to cause infection is by entering the drainage end of the catheter and ascending the inner lumen to the bladder. The 2009 CDC Healthcare Infection Control Practices Advisory Committee (HICPAH) listed a closed urinary drainage system for all catheters as a high priority recommendation, essential for all healthcare organizations caring for patients with catheters. They found both older and more recent data indicating that disconnection of the urine collection device from the catheter is a risk factor for bacteriuria.
In order to maintain a closed urinary drainage system, the catheter generally should not be disconnected from the urine collection device. The most common reason for disconnecting the catheter from the urine collection device is when the catheter needs to be irrigated. Many catheters need to be irrigated several times a day, requiring disconnection of the catheter from the urine collection device and exposing the patient to infection and the clinician to bio-hazardous waste repeatedly.
In order to address the specific problem associated with closed irrigation of a catheter, Russo U.S. Patent Application Pub. No. US 2006/0064065 discloses a closed system irrigation connector for urinary catheters includes a silicone diaphragm that opens when an irrigation device is attached and closes when it is removed. However, the device of Russo does not provide for an aseptic irrigation procedure. In order to maintain an aseptic closed system, anything entering the system should be free of bacteria. This means that the system would ideally have entrance portals that are closed while not being accessed and that are fully sanitizable prior to access.
In order to effectively sanitize a surface, the surface should be easily and fully accessible to apply the needed friction and anti-infective agent. The surface should not have crevices or difficult to reach places, as asperities, steps and other such features can trap bacteria and grow biofilm while remaining shielded from the sanitizing effects of the alcohol swab. The plastic entrance port disclosed by Russo does not have a flat, easily sanitizable surface, but has a crevice that cannot be effectively sanitized. Bacteria hiding on this un-sanitizable surface can enter the system during irrigation and infect the patient.
The second major problem with current catheter systems is that they drain the bladder constantly, not allowing it to fill and empty in a normal manner. This leaves a pool of concentrated, stagnant urine in the neck of the bladder below the drainage holes on the catheter. This stagnant urine serves to create a perfect breeding ground for bacteria. Catheter blockage is another problem with “constant drain” catheter systems and is caused by the buildup of biofilm and salt crystals at the opening of the catheter. Much like a stalactite, the high pH, high mineral fluid in the neck of the bladder provides the perfect environment for this to occur. Bladder spasms can be caused by several factors associated with constant drain systems. The most frequent cause is CAUTI, as already discussed above. With CAUTI, the bladder wall becomes irritated and even swells, causing spasms. The loss of normal stretching and contracting of the detrusor can also cause spasms. Irritation from highly concentrated and high pH urine can also be factor. Bladder wall thickening has also been observed in long-term catheterizations and may be a result of the increasing retention of urine. Catheter-related bladder atony is another complication associated with not allowing the bladder to fill and empty. When the bladder no longer fills and empties in a normal fashion, the detrusor muscle can atrophy, causing a temporary or even permanent inability to void after catheterization. These problems could be solved, at least in part, by allowing the bladder to fill and drain in a more normal fashion.
Many types of valved catheters and universal connections exist that allow for intermittent draining and retention of the bladder. None of the prior art in this area discloses sanitizable surfaces on entry ports leading from the outside to the inside of the closed urinary drainage system. These prior art systems thus often complicate the problem by introducing bacteria into what should be a closed system. A system, method, and apparatus is needed that allows for aseptic irrigation and urine sampling while maintaining a closed system, while allowing for control of urine flow, permitting the bladder to fill and empty as needed or prescribed.
Moreover, disconnection of the urine collection device from the catheter is also desirable for many practical reasons, even if not required for aseptic irrigation and sampling. For example, the need to disconnect the urine collection device arises in the following situations, which can occur several times per day:                1. When the drainage bag needs to be replaced with a new bag.        2. When a patient changes the clothing or underclothing on the lower part of their body.        3. When a patient switches from a bedside urinary drainage bag to a leg drainage bag or vice versa.        4. When it is desirous to temporarily disconnect a urinary collection device from the catheter portion of the system for tests, transfers, bathing and numerous other purposes.        5. When a patient must have a urinary catheter but desires to avoid being connected a urinary collection device for a given time period.        
In order to reuse a urine collection device once it has been disconnected from the system, the connecting end of the urine collection device has to be fully protected from contamination and not come into surface contact with any other non-aseptic surface per the principles of asepsis. It is not adequate to simply swab an exposed unprotected end of a urine collection device that was disconnected from the system with a disinfectant prior to reconnection to the catheter end. This is because the urine collection device is open at the connection end, and bacteria can enter the inside of the urine collection device, which is not sanitizable. Reusable protective covers or sheaths are currently employed to cover the connecting end of the urine collection device when it has been disconnected from the catheter end of the system. However, these reusable covers are generally not adequate and tend to lead to contamination of the system. This is because the covers can be contaminated in between uses and are not sanitizable on the inside surface that comes into contact with the connecting end. As a result, the covers can introduce bacteria to the surface of the connecting end of the urine collection device.
An improved connector system is therefore needed to allow for aseptic disconnection and reconnection of the urine collection device from the catheter in all of the above circumstances while maintaining a closed urinary drainage system under these circumstances.
It is therefore desirable to provide an improved urinary drainage connector system that allows for aseptic disconnection and reconnection of the urine collection device from the catheter, in addition to a system that obviates the need for disconnection during irrigation/sampling.